Transcranial Magnetic Stimulation Theta Burst (TMS), Depression and Smoking.

Overview

This study evaluates de efficacy of Theta Burst Transcranial Magnetic Stimulation (TMS) applied on the left dorsolateral prefrontal cortex in patients with Major Depressive disorder and tobacco consumption.

Full Title of Study: “Transcranial Magnetic Stimulation and Its Effects on Mayor Depressive Disorder and Smoking Cessation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2022

Detailed Description

Major Depressive Disorder (MDD) affects 350 million worldwide causing damage on quality of life and risk behavior such as suicide and smoking. smoking is the second leading cause of death causing about 5 million deaths annually. Theta Burst Stimulation (TBS) is a more tolerable protocol administered at lower intensities and shorter intervals than conventional rTMS protocols.

Interventions

  • Device: Theta Burst Transcranial Magnetic Stimulation
    • Magventure MagPro R30 stimulation Device, MCF-B70 stimulation Coill

Arms, Groups and Cohorts

  • Experimental: 1 session
    • Participants will receive 1 session from monday to friday,during 4 weeks, with 600 total pulses per session
  • Experimental: 3 sessions
    • Participants will receive 3 sessions from monday to friday,during 4 weeks, with 1800 total pulses per session with a 10 minutes rest interval

Clinical Trial Outcome Measures

Primary Measures

  • MINI Neuropsychiatric Interview
    • Time Frame: 15 minutes
    • It is a short structured diagnostic interview that explores the main psychiatric disorders of Axis I of DSM-IV and ICD-10
  • Fagerström test
    • Time Frame: 5 minutes
    • it is a short and simple test consisting of 6 questions. The score ranges from 0-10, so that the higher the score, the greater the dependency. Not only does this test measure physical dependence but it also has therapeutic and prognostic value.
  • Richmond Test
    • Time Frame: 5 minutes
    • Scale consisting of 4 items to assess the degree of motivation to quit smoking on a scale of 1 to 10. For an individual to have expectations of success in a smoking cessation program, they must present a score of 9 or 10 points
  • Glover-Nilsson Test
    • Time Frame: 8 minutes
    • Test consisting of 11 items to measure the psychosocial and behavioral dependence of individuals; it is scored from 0 to 4, with 4 being the maximum score, items 1,4 and 5 measure psychological dependence, questions 2,3,6,7,8,9 and 10 measure behavioral dependence and question 11 measures social dependence.
  • Test of the Unit of the Institute of Public Health of Madrid (UISPM)
    • Time Frame: 10 minutes
    • Test consisting of 23 items divided into 6 modules (stimulation, sedation, automatism, social dependency, psychic dependency and gestural dependency) each item is scored from 0 to 4 being 4 the highest score.
  • Minnesota Nicotine Withdrawal Syndrome Scale (MNWS)
    • Time Frame: 5 minutes
    • This eight-item scale measures withdrawal symptoms (craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia), The score ranges from 0 to 4, with 4 being the highest score, indicating a severe withdrawal syndrome
  • Nicotine Craving Questionnaire (CCN)
    • Time Frame: 8 minutes
    • 12-item questionnaire to assess the degree of craving, with five response options ranging from completely disagree 1 to completely agree 5
  • Paradigm of reactivity to signals and heart rate variability
    • Time Frame: 10 minutes
    • it consists of presenting a series of images that were chosen from the International Series of images for smoking (with neutral counterparts), Version 1.2 (58), the images were presented as follows : 2 blocks of smoking images and 2 blocks with neutral images that are interspersed, each block contains 25 images with a duration of 6 seconds per image, the test has a total duration of 10 minutes; while the participant observes the images, they will place a polar model H10 bluetooh chest strap sensor to measure HRV
  • Co-oximetry
    • Time Frame: 1 minute
    • spectrophotometric technique to detect the loss in the oxygenation capacity of hemoglobin that consists of determining the level of carbon monoxide (CO) in the air exhaled by an individual, levels of 10 or more ppm of CO in the exhaled air correspond to smoking subjects. Levels of 6 to 10 ppm in sporadic smokers, and figures below 6 ppm in non-smokers.
  • Hamilton Rating Depression Scale (HDRS)
    • Time Frame: 10 minutes
    • 21 item, Clinical assessment of depressive symptoms
  • Montgomery-Asberg Rating Depression Scale (MADRS)
    • Time Frame: 10 minutes
    • 10 ítem Clinical assessment of the principal depressive symptoms
  • Hamilton Anxiety Rating Scale (HARS)
    • Time Frame: 10 minutes
    • 14 Ítem clinical scale for rating anxiety symptoms.
  • Beck Depression Invetory (BDI)
    • Time Frame: 10 minutes
    • it´s a 21 ítem self evaluated symptomatology of depression
  • Beck Hopelesness Scale (BHS)
    • Time Frame: 10 minutes
    • is a 20-item self-report inventory designed to measure 3 major aspects of hopelessness (Feelings about the future, loss of self-motivation and expectations)
  • Plutchik Risk Suicide Scale
    • Time Frame: 10 minutes
    • it´s a 26 ítem self-reported scale that assess the intensity of suicidal ideation
  • Beck suicidal ideation scale (BSIS)
    • Time Frame: 10 minutes
    • is an evaluation of suicidal thinking: is an evaluation of suicidal thinking that helps identify individuals at risk of comitting self harm
  • Wisconsin Card Sorting Test (WCST)
    • Time Frame: 20 minutes
    • is a neuropsychological test that assess cognitive flexibility
  • Stop Signal Task
    • Time Frame: 25 minutes
    • is a unique versión of a classic approach to measuring response inhibition

Secondary Measures

  • Marlowe and Crowne Social Desirability Scale
    • Time Frame: 10 minutes
    • self-applied scale consisting of 33 items for the evaluation of the need for social approval, for example, generating a good impression through socially appropriate responses

Participating in This Clinical Trial

Inclusion Criteria

  • With dependence on tobacco use, with depressive symptomatology, that they agree to sign the informed consent letter. Exclusion Criteria:

  • History of head trauma with loss of consciousness, with intracranial metallic objects or metallic plates in the skull, patients with structured suicidal ideation or recent attempts, who suffer from uncontrolled chronic diseases at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases), patients with psychotic symptoms. subjects with alterations in electroencephalogram (epileptiform activity), patients with any type of uncontrolled chronic medical or neurological disease, pregnant women.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dr. Julian Reyes López
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dr. Julian Reyes López, Professor – Universidad Autonoma de Queretaro
  • Overall Official(s)
    • Julian V. Reyes López, PhD, Study Director, Universidad Autónoma de Querétaro
  • Overall Contact(s)
    • sofia cañizares Gómez, master, (442)1910317, soficanizares@gmail.com

Citations Reporting on Results

Fluharty M, Taylor AE, Grabski M, Munafo MR. The Association of Cigarette Smoking With Depression and Anxiety: A Systematic Review. Nicotine Tob Res. 2017 Jan;19(1):3-13. doi: 10.1093/ntr/ntw140. Epub 2016 May 19.

Picciotto MR, Mineur YS. Molecules and circuits involved in nicotine addiction: The many faces of smoking. Neuropharmacology. 2014 Jan;76 Pt B(0 0):545-53. doi: 10.1016/j.neuropharm.2013.04.028. Epub 2013 Apr 28.

Ahern E, Kinsella S, Semkovska M. Clinical efficacy and economic evaluation of online cognitive behavioral therapy for major depressive disorder: a systematic review and meta-analysis. Expert Rev Pharmacoecon Outcomes Res. 2018 Feb;18(1):25-41. doi: 10.1080/14737167.2018.1407245. Epub 2017 Nov 30.

Garcia-Gomez L, Hernandez-Perez A, Noe-Diaz V, Riesco-Miranda JA, Jimenez-Ruiz C. SMOKING CESSATION TREATMENTS: CURRENT PSYCHOLOGICAL AND PHARMACOLOGICAL OPTIONS. Rev Invest Clin. 2019;71(1):7-16. doi: 10.24875/RIC.18002629.

Baeken C, Marinazzo D, Everaert H, Wu GR, Van Hove C, Audenaert K, Goethals I, De Vos F, Peremans K, De Raedt R. The Impact of Accelerated HF-rTMS on the Subgenual Anterior Cingulate Cortex in Refractory Unipolar Major Depression: Insights From 18FDG PET Brain Imaging. Brain Stimul. 2015 Jul-Aug;8(4):808-15. doi: 10.1016/j.brs.2015.01.415. Epub 2015 Feb 7.

Arikan MK, Gunver MG, Tarhan N, Metin B. High-Gamma: A biological marker for suicide attempt in patients with depression. J Affect Disord. 2019 Jul 1;254:1-6. doi: 10.1016/j.jad.2019.05.007. Epub 2019 May 6.

Mahoney JJ 3rd, Hanlon CA, Marshalek PJ, Rezai AR, Krinke L. Transcranial magnetic stimulation, deep brain stimulation, and other forms of neuromodulation for substance use disorders: Review of modalities and implications for treatment. J Neurol Sci. 2020 Nov 15;418:117149. doi: 10.1016/j.jns.2020.117149. Epub 2020 Sep 20.

Filipcic I, Milovac Z, Sucic S, Gajsak T, Filipcic IS, Ivezic E, Aljinovic V, Orgulan I, Penic SZ, Bajic Z. Efficacy, Safety and Tolerability of Augmentative rTMS in Treatment of Major Depressive Disorder (MDD): A Prospective Cohort Study in Croatia. Psychiatr Danub. 2017 Mar;29(1):31-38. doi: 10.24869/psyd.2017.31.

Czeisler ME, Lane RI, Petrosky E, Wiley JF, Christensen A, Njai R, Weaver MD, Robbins R, Facer-Childs ER, Barger LK, Czeisler CA, Howard ME, Rajaratnam SMW. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic – United States, June 24-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1049-1057. doi: 10.15585/mmwr.mm6932a1.

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